ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCI), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.

ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.

Pump tubing-flexis used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, Omnipaque™ single dose bottles, or Visipaque™ single dose bottles, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first. Time per contrast media or saline container depends on each contrast media's or saline's use time expiration with a maximum of eight (8) hours per contrast media or saline container.

Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

Device Description

ulrichINJECT CT motion is a syringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subjects underqoing diagnostic examinations in computed tomography (CT) applications.

The ulrichINJECT CT motion system consists of the CT motion terminal, CT motion injector and the CT motion tubing system. The CT motion tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The CT motion tubing system consists of three components:

. Spike for CT
. Pump tubing-flex
. Patient Tubing

ulrichINJECT CT motion uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the CT motion tubing system (spikes for CT, CT motion pump tubing-flex, and patient tubing for pump tubing-flex).

The updated ulrichINJECT CT motion system is intended to be used with the following components that are not supplied with the system:

Multiple patient use saline containers, .
Omnipaque IBP contrast media containers, .
. Omnipaque single-dose contrast media bottles,
. Visipaque single-dose contrast media bottles, and
. Cannula.

The updated ulrichINJECT CT motion system is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.

ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the device. Controls include air detectors, which are designed to detect air without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.

The ulrichINJECT CT motion is provided in three versions:

. Mobile pedestal version
Ceiling version ●
Wall mounted version ●

AI/ML Overview

This document describes the ulrichINJECT CT motion, a syringeless contrast media management system for CT applications. The submission to the FDA (K192872) is seeking to market the device as substantially equivalent to a previously cleared version (K171392). The main changes mentioned are the support for additional contrast media (Omnipaque single dose and Visipaque single dose) and a new Li-ion battery option.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, concise format. Instead, it details various non-clinical tests performed and states that the device "complies with the standards listed" or "met the requirements of the pre-defined acceptance criteria."

Therefore, I will extrapolate the acceptance criteria and performance based on the described tests and the "Comparison" column in the detailed comparison table, where the subject device is deemed "identical" or "equivalent" to the predicate.

Extrapolated Acceptance Criteria and Reported Device Performance (Based on "Comparison" and "Non-Clinical Testing" sections):

Acceptance Criteria Category	Performance Criterion (Extrapolated)	Reported Device Performance (Summary from document)
Indications for Use	Be indicated for controlled, automatic administration of contrast media and saline on the venous side for CT applications. Support Omnipaque™ IBP, Omnipaque™ single dose, and Visipaque™ single dose. Maintain specified tubing use times (Pump tubing-flex 24 hours, Patient tubing per patient, Spike for CT single bottle).	Met. Intended use and indications are identical to predicate, with the addition of Omnipaque single dose and Visipaque single dose, which are stated not to affect intended use or safety/effectiveness. Tubing use times are identical to predicate.
System Components	Injector Head, Touch Terminal, Injector Base, Wall Mount, Ceiling Mount, Contrast Media Housing with Heater, and specified disposables (Pump Tubing-flex, Patient Tubing, Spike for CT) must be present and function as per predicate.	Met. System components and disposables are identical to the predicate (K171392).
Physical Design	Weight, dimensions, and power requirements must be identical to predicate.	Met. Weight, dimensions, and power requirements are identical to predicate.
Battery	New Li-Ion battery must not affect intended use, safety, or effectiveness.	Met. The new Li-Ion battery option is a difference from the predicate but is stated not to affect the intended use, safety, or effectiveness of the device. (Implies testing was done to confirm this, though specific results aren't detailed in the table).
Display Type	Color LCD Terminal with touch screen.	Met. Identical to predicate.
Operational Characteristics	Syringeless system, remote operation via Touch Terminal, single-patient use disposable (Patient Tubing), prevention of reusable disposables via software, rotary peristaltic pump, administration of contrast media and saline, use of spikes for media containers.	Met. All operational characteristics are identical to the predicate.
Safety Mechanisms	Multi-layered software stops, used Patient Tubing/Pump Tubing-flex detectors, volume remaining readout (if programmed > remaining), programmable pressure limit (195 PSI), safety feature against reuse of patient tubing and spikes.	Met. All safety mechanisms are identical to the predicate.
Injection Capabilities	40 phases per protocol. Injection rates for contrast media and saline (0.1 mL/s to 10.0 mL/s). Injection volume (1-200 mL contrast, 400 mL total media per patient). Injection pause (0-999 sec). Injection protocol storage. Priming/Venting Rate (2 mL/s manual).	Met. All injection capabilities are identical to the predicate.
Flow Rate and Volume Accuracy	Volume accuracy of ± 5% for 10-200 mL contrast media. Flow rate accuracy of ± 5%.	Met. Identical to predicate.
Compatible Contrast Media	Must be compatible with Omnipaque™ IBP, Omnipaque™ single dose, and Visipaque™ single dose, without compromise to chemical integrity.	Met. Chemical compatibility testing concluded the system does not interact with Omnipaque™ or Visipaque™, and their chemical integrity is not compromised. This difference from the predicate was addressed with contamination control, extractables/leachables studies, and bench testing.
Contrast Media Container Volume	System supports 500 mL (OMNIPAQUE™ IBP), 100 mL and 150 mL (VISIPAQUE™ single dose), 150 mL (OMNIPAQUE™ single dose).	Met. Equivalent to predicate; additional volumes for Omnipaque and Visipaque addressed with a process simulation study.
Air Detection	Ultrasound principle. Technical detection limit of air in tubing 0.05 mL. Air detector alarm limit 1 mL.	Met. Identical to predicate.
Occlusion Detection	Fail-safe piezo-resistive pressure sensor principle. Occlusion detection alarm limit 246 PSI.	Met. Identical to predicate.
Sterilization	EtO sterilization to a sterility assurance level of 10-6 in accordance with ISO 11135-1. Packaging validated per ISO 11607-1.	Met. Verification results indicate compliance with ISO 11135-1 and ISO 11607-1.
Shelf-Life	Real-time and accelerated aging studies confirm specified shelf-life.	Met. Additional real-time aging shelf-life data provided for this submission. The ulrichINJECT CT motion tubing system's packaging was validated per ISO 11607-1.
Contamination Control	Ability to maintain sterility and resist microorganism ingress with Omnipaque IBP, Omnipaque single dose, and Visipaque single dose. Residuals between active compounds within defined limits after rinsing.	Met. Studies (Process Simulation, Microbial Ingress, Cross Contamination, Rinsing) concluded the device maintains sterility and resists ingress with the listed contrast media, and residuals are within defined limits.
Biocompatibility	Indirect patient contact materials verified per ISO 10993-1, including tests for cytotoxicity, intracutaneous reactivity, allergic sensitization, systemic acute toxicity, pyrogens, hemocompatibility (hemolysis), and LAL test.	Met. Verification results indicated compliance with ISO 10993-1 for the listed tests.
Extractables and Leachables	Testing and toxicological assessment demonstrate safety and effectiveness for intended uses, meeting pre-defined acceptance criteria for Omnipaque and Visipaque.	Met. Testing for extractables and leachables for VISIPAQUE, along with a toxicological assessment, met pre-defined acceptance criteria, demonstrating safety and effectiveness. (OMNIPAQUE testing was previously done for K171392).
Performance - Bench	Conformance to predetermined specifications and applicable standards (e.g., applicable requirements from ISO 8536-4). Confirmation that mixing of contrast media will not occur.	Met. Testing confirmed conformance to specifications and applicable standards. Additional verification testing confirmed no mixing of contrast media. Transport validation and cleaning instructions validation were also performed.
Software Validation	Conformance with established performance criteria through Installation Qualification and Operational/Performance Qualification, following FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff" (2005).	Met. Software V&V was repeated for updates, following FDA guidance. IQ and O/PQ criteria were met, and the software was released for intended use.
Electromagnetic Compatibility / Electrical Safety	Conformance with IEC 60601-1 and related collateral standards (e.g., IEC 60601-1-2 4th edition).	Met. Testing results indicate compliance with IEC 60601-1, IEC 60601-1-2 (4th edition).

Study Information:

The provided document describes a 510(k) submission (K192872) for the ulrichINJECT CT motion system. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a predicate device (K171392), rather than prove de novo safety and effectiveness through extensive clinical trials. Therefore, the "studies" described are primarily non-clinical verification and validation activities.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- For physical components and engineering performance (Flow Rate, Volume Accuracy, Pressure Limits, Air Detection, etc.): The document does not specify a numerical sample size for bench tests. It refers to "verification testing" and "additional verification testing," implying that a sufficient number of tests were conducted to confirm performance parameters against established specifications and standards.
- For chemical compatibility, contamination control, biocompatibility, and extractables/leachables: These tests typically involve a sample of the device materials and exposure to the specified substances or conditions, but a specific number is not provided.
- For software validation: No specific number of test cases or iterations is provided, but it states "Validation included an installation qualification and an operational / performance qualification."
Data Provenance: The studies are non-clinical (bench testing, lab studies). The country of origin of the data is not explicitly stated, but the submitter (ulrich GmbH & Co. KG) is located in Germany. These studies are prospective in the sense that they were conducted specifically for this submission to address the changes and confirm substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. For this type of non-clinical, engineering, and laboratory-based verification and validation, "ground truth" as established by human experts (like radiologists) is not the primary method. Instead, "ground truth" is typically defined by:
- Established engineering specifications and performance targets.
- International and national consensus standards (e.g., ISO, IEC).
- Regulatory guidance documents (e.g., FDA software guidance).
- Pre-defined acceptance criteria derived from these specifications and standards.
- Laboratory analysis results (e.g., chemical assays, microbiological cultures, physical measurements).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 (two readers plus one adjudicator) are used in clinical studies involving human interpretation or subjective assessments. The studies presented here are non-clinical verification and validation tests, where results are typically objectively measured against predefined criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is an angiographic injector, a hardware-based system for delivering contrast media, not an AI software intended for image interpretation or diagnosis. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical injector system with embedded software, not a standalone algorithm or AI software. Its performance is inherent to its mechanical and electronic function, although the software controls are crucial for its operation. The performance described is "algorithm only" in the sense that it's the device's intrinsic mechanical/software behavior being tested, but not an AI algorithm performing a diagnostic task.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical studies relies on:
- Engineering specifications and design requirements: For physical dimensions, weights, power, injection rates, volumes, accuracies, and programmable limits.
- Consensus standards: Such as ISO 11135-1 (sterilization), ISO 11607-1 (packaging), ISO 10993-1 (biocompatibility), IEC 60601-1/60601-1-2 (electrical safety, EMC), and applicable parts of ISO 8536-4 (infusion equipment).
- Laboratory test results: For chemical compatibility, extractables and leachables (chemical analysis), and contamination control (microbiological assays).
- Software validation protocols: Defining expected behavior and outputs.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that requires a "training set" of data in the conventional sense. The software validation refers to qualification, not machine learning model training.

9. How the ground truth for the training set was established

Not applicable. As there is no machine learning "training set," there is no "ground truth" established for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 2, 2020

ulrich GmbH & Co. KG % Rita King CEO MethodSense, Inc. 1 Copley Parkway. Suite 410 Morrisville, North Carolina 27560

Re: K192872

Trade/Device Name: ulrichINJECT CT Motion Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: IZO Dated: May 29, 2020 Received: June 2, 2020

Dear Rita King:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Summary of 510(k)

Ulrich GmbH & Co. KG

K192872

This 510(k) Summary is in conformance with 21CFR 807.92

Submitter:	ulrich GmbH & Co. KGBuchbrunnenweg 1289081 UlmGermanyPhone: +49 731 9654-1714Fax: +49 731 9654-2807
Primary Contact:	Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979
Company Contact:	Sven ErdmannDirector Development & Product Management Devices
Date Prepared:	May 29, 2020

Device Name and Classification

Trade Name:	ulrichINJECT CT motion
Common Name:	Contrast Media Management System
Classification:	Class II
Regulation Number:	21 CFR 870.1650, Angiographic Injector and Syringe
Classification Panel:	Cardiovascular Panel
Product Code:	IZQ

Predicate Device:

	Predicate
Trade Name	ulrichINJECT CT motion
Common Name	Contrast Media Management System
510(k) Submitter / Holder	Class II
510(k) Number	K171392
Regulation Number	21 CFR 870.1650, Angiographic Injector and Syringe
Classification Panel	Cardiovascular Panel
Product Code	IZQ

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Device Description

. Spike for CT
. Pump tubing-flex
. Patient Tubing

The updated ulrichINJECT CT motion system is intended to be used with the following components that are not supplied with the system:

Multiple patient use saline containers, .
Omnipaque IBP contrast media containers, .
. Omnipaque single-dose contrast media bottles,
. Visipaque single-dose contrast media bottles, and
. Cannula.

The ulrichINJECT CT motion is provided in three versions:

. Mobile pedestal version
Ceiling version ●
Wall mounted version ●

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The mobile pedestal version consists of the iniector head and the iniector base and has been updated to operate with a rechargeable Li-ion battery or lead gel battery in addition to the power supply. The ceiling version and the wall mounted version consist of the injector head, a fixed height arm, and a movable arm.

Indications for Use

Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

Risk Analvsis Method

The updated ulrichINJECT CT motion system was assessed to determine the risks to health associated with the use of the device specifically as it relates to the use of OMNIPAQUE and VISIPAQUE single dose bottles and the new Li-ion battery. Risks related to safety. contamination and usability were considered. A risk analysis was conducted in accordance with ISO 14971:2007, Medical devices -- Application of risk management to medical devices. Several risks were assessed, including, but not limited to, device malfunction, mixing of contrast media, contamination and infection, and improper use.

Substantial Equivalence

ulrichINJECT CT motion is substantially equivalent to the ulrichINJECT CT motion system (K171392) currently on the market.

The table below provides a detailed comparison of ulrichINJECT CT motion to the predicate device.

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Detailed Comparison of the Subject and Predicate Device

Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
Indications for Use	ulrichINJECT CT motion is a contrastmedia management system that isindicated for the controlled, automaticadministration, on the venous side, ofcontrast media and saline (NaCl), tohuman subjects undergoing diagnosticexaminations in computed tomography(CT) applications.ulrichINJECT CT motion is specificallyindicated for use in CT procedures forthe delivery of Omnipaque™ (lohexol)Injection, solution - GE Healthcare Inc.contrast media as supplied in ImagingBulk Packages (IBP), Omnipaque™(lohexol) Injection, solution – GEHealthcare Inc., and Visipaque™(iodixanol) Injection - GE HealthcareInc. contrast media as supplied insingle dose bottles.Pump tubing-flex is used for amaximum time of twenty four (24)hours. When used with Omnipaque™IBP, Omnipaque™ single dose bottles,or Visipaque™ single dose bottles, amaximum of 19 bottles of contrastmedia can be used or maximum timeof twenty four (24) hours of Pumptubing-flex, or whichever comes first.Time per contrast media or salinecontainer depends on each contrast	ulrichINJECT CT motion is a contrastmedia management system that isindicated for the controlled, automaticadministration, on the venous side, ofcontrast media and saline, to humansubjects undergoing diagnosticexaminations in computed tomography(CT) applications.ulrichINJECT CT motion is specificallyindicated for use in CT procedures forthe delivery of Omnipaque™ (lohexol)Injection, solution - GE Healthcare Inc.contrast media as supplied in ImagingBulk Packages (IBP).Pump tubing-flex is used for amaximum time of twenty four (24)hours. When used with Omnipaque™IBP, a maximum of 19 bottles ofcontrast media can be used ormaximum time of twenty four (24)hours of pump tubing-flex, orwhichever comes first, with a maximumof eight (8) hours per contrast media orsaline container.Spike for CT disposable is for single-bottle use only and must be discardedwith the media container. The patienttubing must be discarded after eachpatient procedure.	The intended use of theulrichINJECT CT motion isidentical to the intended use ofthe previously clearedulrichINJECT CT motion(K171392).The indications for use of theulrichINJECT CT motion areequivalent to the indicationsfor use of the previouslycleared ulrichINJECT CTmotion (K171392).The only difference is that theulrichINJECT CT motionsupports two additionalcontrast media, OMNIPAQUEsingle dose and VISIPAQUEsingle dose. This differencedoes not affect the intendeduse or safety andeffectiveness of the device.
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
	media's or saline's use time expiration,with a maximum of eight (8) hours percontrast media or saline container.Spike for CT disposable is for single-bottle use only and must be discardedwith the media container. The Patienttubing must be discarded after eachpatient procedure.ulrichINJECT CT motion is to be usedonly by and under quasi-continuoussupervision of trained healthcareprofessionals in an appropriatelicensed healthcare facility, in a roomdesignated for radiological proceduresthat involve intravascularadministration of contrast agent.	ulrichINJECT CT motion is to be usedonly by and under quasi-continuoussupervision of trained healthcareprofessionals in an appropriatelicensed healthcare facility, in a roomdesignated for radiological proceduresthat involve intravascularadministration of contrast agent.
System Components
System	Injector HeadTouch Terminal	Injector HeadTouch Terminal	The system components of theulrichINJECT CT motion areidentical to the systemcomponents of the previouslycleared ulrichINJECT CTmotion (K171392).
Accessories	Injector BaseWall Mount with moveable armCeiling Mount with moveable armContrast Media Housing with Heater	Injector BaseWall Mount with moveable armCeiling Mount with moveable armContrast Media Housing with Heater	The accessories of theulrichINJECT CT motion areidentical to the systemcomponents of the previouslycleared ulrichINJECT CTmotion (K171392).
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
Disposables	ulrichINJECT CT Motion Pump Tubing-flexPatient Tubing for Pump Tubing-flexulrichINJECT CT Motion Spike for CT	ulrichINJECT CT Motion Pump Tubing-flexPatient Tubing for Pump Tubing-flexulrichINJECT CT Motion Spike for CT	The disposables of theulrichINJECT CT motion areidentical to the disposables ofthe previously clearedulrichINJECT CT motion(K171392).
Physical Design
Weight	Injector (pedestal version): Approx. 80kgInjector (ceiling and wall mountversion): Approx. 40 kgTerminal: Approx. 3 kg	Injector (pedestal version): Approx. 80kgInjector (ceiling and wall mountversion): Approx. 40 kgTerminal: Approx. 3 kg	The weight of theulrichINJECT CT motion isidentical to the weight of thepreviously clearedulrichINJECT CT motion(K171392).
Dimensions	Injector (pedestal version and wallmount version): 64.5 x 64.5 x 144.5 cmInjector (ceiling version): Depends onthe system selected and the length ofthe fixed height armTerminal: 31 x 27.5 x 17 cm	Injector (pedestal version and wallmount version): 64.5 x 64.5 x 144.5 cmInjector (ceiling version): Depends onthe system selected and the length ofthe fixed height armTerminal: 31 x 27.5 x 17 cm	The dimensions of theulrichINJECT CT motion areidentical to the dimensions ofthe previously clearedulrichINJECT CT motion(K171392).
Power RequirementRated Voltage:Rated Current:Rated Frequency:	110 to 240 V AC1.6 A50/60Hz	110 to 240 V AC1.6 A50/60Hz	The power requirements of theulrichINJECT CT motion areidentical to the powerrequirements of the previouslycleared ulrichINJECT CTmotion (K171392).
Battery	Lead gel battery or Li-Ion battery	Lead gel battery	The battery of theulrichINJECT CT motion isdifferent from the previouslycleared ulrichINJECT CTmotion (K171392). Thisdifference does not affect theintended use or safety oreffectiveness of the device.
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
Display Type	Color LCD Terminal with touch screen	Color LCD Terminal with touch screen	The display of theulrichINJECT CT motion isidentical to the display of thepreviously clearedulrichINJECT CT motion(K171392).
Characteristics
Syringeless system	Yes	Yes	ulrichINJECT CT motion isidentical to the previouslycleared ulrichINJECT CTmotion (K171392). Bothsystems are syringeless.
Remote Operation	Yes, via the Touch Terminal	Yes, via the Touch Terminal	ulrichINJECT CT motion isidentical to the previouslycleared ulrichINJECT CTmotion (K171392). Bothsystems provide remoteoperation.
Single Patient UseDisposable	Patient Tubing for Pump Tubing-flex	Patient Tubing for Pump Tubing-flex	The single patient usedisposable of theulrichINJECT CT motion isidentical to the previouslycleared ulrichINJECT CTmotion (K171392).
Designed to PreventReuse of Disposables	Yes - via the use of software controls	Yes - via the use of software controls	ulrichINJECT CT motion isidentical to the previouslycleared ulrichINJECT CTmotion (K171392). Bothsystems provide softwarecontrols to prevent user fromreuse of disposables.
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
Rotary peristalticpump	Yes	Yes	The rotary peristaltic pump ofthe ulrichINJECT CT motion isidentical to the rotaryperistaltic pump of thepreviously clearedulrichINJECT CT motion(K171392).
Used to administercontrast media andsaline	Yes	Yes	ulrichINJECT CT motion isidentical to the previouslycleared ulrichINJECT CTmotion. Both systems areused to administer contrastmedia and saline.
Disposable usesspikes to spike mediacontainer	Yes	Yes	ulrichINJECT CT motion isidentical to the previouslycleared ulrichINJECT CTmotion. Both systems havedisposables which use spikesto spike media containers.
Safety StopMechanism	Multi-layered software stops; UsedPatient Tubing detector and PumpTubing-flex detector	Multi-layered software stops; UsedPatient Tubing detector and PumpTubing-flex detector	The safety stop mechanism ofthe ulrichINJECT CT motion isidentical to the safety stopmechanism of the previouslycleared ulrichINJECT CTmotion.
Volume RemainingReadout	Yes, displayed on control unit ifprogrammed volume is higher thanremaining volume	Yes, displayed on control unit ifprogrammed volume is higher thanremaining volume	The volume remaining readoutof the ulrichINJECT CT motionis identical to the volumeremaining readout of thepreviously clearedulrichINJECT CT motion.
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
ProgrammablePressure Limit	Yes, 195 PSI; user-programmable orautomatic	Yes, 195 PSI; user-programmable orautomatic	The programmable pressurelimit of the ulrichINJECT CTmotion is identical to theprogrammable pressure limitof the previously clearedulrichINJECT CT motion.
Operational Characteristics
Injection Capabilities	40 phases per protocol	40 phases per protocol	The injection capabilities of theulrichINJECT CT motion areidentical to the injectioncapabilities of the previouslycleared ulrichINJECT CTmotion.
Injection Rates forContrast Media	0.1 mL/s to 10.0 mL/s	0.1 mL/s to 10.0 mL/s	The injection rates for contrastmedia of the ulrichINJECT CTmotion are identical to theinjection rates for contrastmedia of the previouslycleared ulrichINJECT CTmotion.
Injection Rates forSaline	0.1 mL/s to 10.0 mL/s	0.1 mL/s to 10.0 mL/s	The injection rates for saline ofthe ulrichINJECT CT motionare identical to the injectionrates for saline of thepreviously clearedulrichINJECT CT motion.
Injection Volume perInjection	1 to 200 mL max volume of contrastmedia per patient with a max of 400mL total media (contrast and saline)per patient	1 to 200 mL max volume of contrastmedia per patient with a max of 400mL total media (contrast and saline)per patient	The injection volume perinjection of the ulrichINJECTCT motion is identical to theinjection volume per injectionof the previously clearedulrichINJECT CT motion.
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
Flow Rate andVolume Accuracy	10-200 mL of contrast media withvolume accuracy of ± 5%Flow rate accuracy of ± 5%	10-200 mL of contrast media withvolume accuracy of ± 5%Flow rate accuracy of ± 5%	The flow rate and volumeaccuracy of the ulrichINJECTCT motion is identical to theflow rate and volume accuracyof the previously clearedulrichINJECT CT motion.
Contrast MediaContainer Volume	500 mL (OMNIPAQUE™ IBP)100 mL and 150 mL (VISIPAQUE™single dose)150 mL (OMNIPAQUE™ single dose)	500 mL (OMNIPAQUE™ IBP)	The contrast media containervolume of the ulrichINJECTCT motion is equivalent to thecontrast media containervolume of the previouslycleared ulrichINJECT CTmotion.The only difference is that theulrichINJECT CT Motionincludes an additional contrastmedia container volumes forOmnipaque and Visipaque.This difference has beenaddressed with the completionof a process simulation study.
Compatible ContrastMedia	OMNIPAQUE™ IBPOMNIPAQUE™ single doseVISIPAQUE™ single dose	OMNIPAQUE™ IBP	The compatible contrast mediaof the ulrichINJECT CT motionis different from the compatiblecontrast media of thepreviously clearedulrichINJECT CT motion.
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
			This difference has beenaddressed with the completionof contamination controlstudies, extractable andleachable studies, and benchtesting.
Saline Flush	Yes	Yes	The saline flush feature of theulrichINJECT CT motion isidentical to the saline flushfeature of the previouslycleared ulrichINJECT CTmotion.
Needle Size	14-24 G	14-24 G	The needle size of theulrichINJECT CT motion isidentical to the needle size ofthe previously clearedulrichINJECT CT motion.
Injection Pause	Programmable - 0 sec to 999 sec in 1sec increments	Programmable - 0 sec to 999 sec in 1sec increments	The injection pause of theulrichINJECT CT motion isidentical to the injection pauseof the previously clearedulrichINJECT CT motion.
Injection ProtocolStorage	Yes	Yes	The injection protocol storageof the ulrichINJECT CT motionis identical to the injectionprotocol storage of thepreviously clearedulrichINJECT CT motion.
Priming/Venting Rate	2 mL/s (manual)	2 mL/s (manual)	The priming/venting rate of theulrichINJECT CT motion isidentical to the priming/ventingrate of the previously clearedulrichINJECT CT motion.
Characteristic	ulrichINJECT CT motion( Subject Device )	ulrichINJECT CT motion (K171392)( Primary Predicate )	Comparison
Air DetectionPrinciple	Ultrasound	Ultrasound	The air detection principle of the ulrichINJECT CT motion is identical to the air detection principle of the previously cleared ulrichINJECT CT motion.
Technical DetectionLimit of air in tubing	0.05 mL	0.05 mL	The technical detection limit of air in tubing of the ulrichINJECT CT motion is identical to the technical detection limit of air in tubing of the previously cleared ulrichINJECT CT motion.
Air Detector AlarmLimit	1 mL	1 mL	The air detector alarm limit of the ulrichINJECT CT motion is identical to the air detector alarm limit of the previously cleared ulrichINJECT CT motion.
Occlusion DetectionPrinciple	Fail safe piezo-resistive pressuresensor	Fail safe piezo-resistive pressuresensor	The occlusion detection principle of the ulrichINJECT CT motion is identical to the occlusion detection principle of the previously cleared ulrichINJECT CT motion.
Occlusion DetectionAlarm Limit	246 PSI	246 PSI	The occlusion detection alarm limit of the ulrichINJECT CT motion of the occlusion detection alarm limit of the previously cleared ulrichINJECT CT motion.
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
Disposables
Time Limit forDisposables	24 hours for ulrichINJECT CT MotionPump Tubing-flex12 hours for Patient Tubing for PumpTubing-flex8 hours for ulrichINJECT CT MotionSpike for CT	24 hours for ulrichINJECT CT MotionPump Tubing-flex12 hours for Patient Tubing for PumpTubing-flex8 hours for ulrichINJECT CT MotionSpike for CT	The time limit for disposablesof the ulrichINJECT CT motionis identical to the time limit fordisposables of the previouslycleared ulrichINJECT CTmotion.
Package Sterile	Yes	Yes	The sterile packaging of theulrichINJECT CT motiondisposables is identical to thesterile packaging of thepreviously clearedulrichINJECT CT motion.
Sterilization Method	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	The sterilization method of theulrichINJECT CT motion isidentical to the sterilizationmethod of the previouslycleared ulrichINJECT CTmotion.
PackagingConfiguration	Tyvek lid covering polystyrele tray	Tyvek lid covering polystyrele tray	The packaging configuration ofthe ulrichINJECT CT motion isidentical to the sterilizationmethod of the previouslycleared ulrichINJECT CTmotion.
Patient Tubing
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
Components	Patient TubingTwo Patient Luer Connectors withsafety capsTwo check valves	Patient TubingTwo Patient Luer Connectors withsafety capsTwo check valves	The patient tubingcomponents of theulrichINJECT CT motion areidentical to the patient tubingcomponents of the previouslycleared ulrichINJECT CTmotion.
Safety FeatureAgainst Re-use	Yes, via software controls	Yes, via software controls	The safety features to protectagainst reuse of patient tubingfor the ulrichINJECT CTmotion are identical to thesafety features to protectagainst reuse of patient tubingfor the previously clearedulrichINJECT CT motion.
Pump Tubing-flex
Components	Contrast media lines x2Saline LineW-piecePressure sensor unit with integratedparticle filterCheck valveSwabable valves x 4	Contrast media lines x2Saline LineW-piecePressure sensor unit with integratedparticle filterCheck valveSwabable valves x 4	The pump-tubing flexcomponents of theulrichINJECT CT motion areidentical to the pump-tubingflex components of thepreviously clearedulrichINJECT CT motion.
Contrast Media LineTubing Material	PVC / PUR	PVC / PUR	The pump tubing-flex contrastmedia line tubing material ofthe ulrichINJECT CT motion isidentical to the pump tubing-flex contrast media line tubingmaterial of the previouslycleared ulrichINJECT CTmotion.
Characteristic	ulrichINJECT CT motion(Subject Device)	ulrichINJECT CT motion (K171392)(Primary Predicate)	Comparison
Saline Line TubingMaterial	PVC / PUR	PVC / PUR	The pump tubing-flex salineline tubing material of theulrichINJECT CT motion isidentical to the pump tubing-flex saline line tubing materialof the previously clearedulrichINJECT CT motion.
Spike for CT
Spike Size	28.5 mm	28.5 mm	The spike size of theulrichINJECT CT motion isidentical to the spike size ofthe previously clearedulrichINJECT CT motion.
Safety FeatureAgainst Re-Use	Yes, via software controls	Yes, via software controls	The safety feature against re-use of spikes for theulrichINJECT CT motion isidentical to the safety featureagainst re-use of spikes for thepreviously clearedulrichINJECT CT motion.

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In conclusion, the intended use for ulrichINJECT CT motion is the same as that of the previously cleared ulrichINJECT CT motion (K171392). The technological characteristics demonstrate that the ulrichINJECT CT motion is equivalent to previously cleared ulrichINJECT CT motion (K171392), and the testing shows that the ulrichINJECT CT motion is substantially equivalent to the previously cleared ulrichNJECT CT motion (K171392) and assures that the ulrichNJECT CT motion is as safe and effective as the previously cleared ulrichINJECT CT motion (K171392).

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Non-Clinical Testing

ulrichINJECT CT motion system and software were validated in accordance with a Verification & Validation plan to ensure conformance with established performance criteria.

Software:

Software verification and validation was performed as part of K171392 and has been repeated for the software updates made as part of this submission. FDA's guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff" (2005) has been followed.

Validation included an installation qualification and an operational / performance qualification. The ulrichINJECT CT motion software is unconditionally acceptance criteria for the Installation Qualification and Operational and Performance Qualification are satisfactorily met so that the Software is released for its intended use.

Electromagnetic Compatibility / Electrical Safety

Testing was performed in accordance with the following standards as part of K171392:

. IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2: Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests

Additional EMC Testing has been performed to demonstrate conformance to IEC 60601-1-2 4th edition.

Testing results indicate that the ulrichINJECT CT motion complies with the standards listed.

Sterilization:

The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10-6 in accordance with the following standard prior to commercial distribution:

. ISO 11135-1: Sterilization of health care products-Ethylene oxide - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices; 2007
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.

Shelf-Life:

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Real time aging and accelerating aging studies were performed as part of K171392. Additional real time aging shelf-life data is also provided for this submission. The ulrichINJECT CT motion tubing system is sterilized and its packaging was validated in accordance with the following standard:

ISO 11607-1: Packaging for terminally sterilized medical devices Part 1: requirements . for materials, sterile barrier systems and packaging systems; 2006
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.

Chemical Compatibility

Material compatibility of the ulrichINJECT CT motion tubing system was performed using Omnipaque™ and Visipaque™ as the solvents. The results of the testing concluded that the ulrichINJECT CT motion tubing system does not interact with Omnipaque™ or Visipaque™ and the chemical integrity of Omnipaque™ or Visipaque™ is not compromised throughout use. Therefore, ulrichINJECT CT motion is safe and effective for its intended uses.

Contamination Control:

ulrich has performed the following contamination control studies:

. Process Simulation Studies
. Microbial Ingress Study
Cross Contamination Study
. Rinsing Study

Contamination control study results has concluded that ulrichINJECT CT motion has the ability to maintain the sterility of the injection media and resist the ingress of microorganisms when used with Omnipaque™ Imaging Bulk Package (IBP), Omnipaque single dose bottles, and Visipaque single dose bottles during its intended use. Additionally, it has been concluded that the residuals between the single active compounds (lohexol and lodixanol) after rinsing the system with physiological saline solution are within the defined limits.

Biocompatibility:

The ulrichINJECT CT motion tubing system indirect patient contact materials were verified in accordance with the following standard as part of K171392:

. ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process: 2009
The following tests have been performed:
. Cytotoxicity
Intracutaneous reactivity
Allergic sensitization
Systemic acute toxicity
Pyrogens

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. Hemocompatibility: Hemolysis
LAL test: Bacterial endotoxins ●

Verification results indicated that the materials comply with the standard.

Extractables and Leachables

Testing was performed for extractables and simulation testing for leachable compounds and particulates as part of K171392 for OMNIPAQUE. This testing was repeated for VISIPAQUE for this submission.

Testing and a toxicological assessment demonstrated that ulrichINJECT CT motion is safe and effective for its intended uses. The results of the testing and toxicological assessment met the requirements of the pre-defined acceptance criteria for the intended uses of the device.

Performance - Bench:

The ulrichINJECT CT motion tubing system was tested for performance and verified in accordance with the following standards as part of K171392:

ISO 8536-4: Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; 2010
ulrichINJECT tubing system is not a gravity feed device. Therefore, only the applicable requirements from ISO 8536-4 were tested.

Transport validation and cleaning instructions validation was also performed as part of K171392.

Although the components of ulrichINJECT CT motion system have not changed since K171392, additional verification testing has been performed to further confirm that mixing of contrast media will not occur.

Test and verification results indicate that the ulrichINJECT CT motion tubing system conforms to its predetermined specifications and the applicable standards

Conclusion

Based on the performance testing, comparison, and analysis in this submission, the subject device ulrichINJECT CT motion is substantially equivalent to the predicate device, K171392.

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.